News Archive

EMA - Implementation strategy for ICH M10

6th December 2023

The EMA has issued their implementation strategy for ICH M10 – public consultation is open until until 31 January 2024.

Read More+

FDA - FDA Roundup, 5th December 2023

6th December 2023

An at-a-glance summary of news from around the agency,.

Read More+

EMA - Consumption of antimicrobials in animals reaches lowest level ever in Europe

22nd November 2023

European countries have substantially reduced sales of veterinary antibiotics, which translates into a lower risk of bacteria becoming resistant in people and animals.

Read More+

EMA - Small and Medium-Sized Enterprises Newsletter

22nd November 2023

Issue 60

Read More+

FDA - FDA Roundup: 21 November, 2023

22nd November 2023

An at-a-glance summary of news from around the agency

Read More+

MHRA - International Recognition Procedure Updates

22nd November 2023

MHRA added guidance on the Eligibility Checker and submitting your Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle to the International Recognition Procedure pages of it's website.

Read More+

MHRA - MHRA launches online Eligibility Checker tool for applications via the new International Recognition Procedure (IRP)

22nd November 2023

IRP is expected to further help bringing life-saving new medicines to UK patients from 1 January 2024

Read More+

MHRA - Performance Metrics

22nd November 2023

Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments

Read More+

MHRA - Performance Metrics January 2023 – October 2023: Assessment of New Marketing Authorisation Applications and Variations

22nd November 2023

MHRA performance - Assessment of New Marketing Authorisation Applications and Variations

Read More+

MHRA Blog - Antimicrobial resistance: How we’re supporting innovative solutions to a looming global health emergency

22nd November 2023

World AMR Awareness Week (WAAW) is an annual global campaign from 18-24 November that raises awareness and understanding of antimicrobial resistance (AMR), a global health issue worsened by the misuse of antimicrobial agents such as antibiotics.

Read More+